New Public Citizen Health Lead To Keep Banging Drum On Stronger Benefit-Risk Ratios
Robet Steinbrook, the third director of the 50-year-old health group, plans to stay true to the organization’s long-held mission of holding FDA drug approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.
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Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.
FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.